N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE— 510(k) K992170
Substantially EquivalentBest Manufacturing Company
FDA 510(k) clearance K992170 for N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE, Substantially Equivalent on 1999-09-07. Applicant: Best Manufacturing Company. Device class: 1.
Clearance details
- Applicant
- Best Manufacturing Company
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo, GA, US
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More clearances from Best Manufacturing Company
view all- K022024 — NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
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- K012166 — NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
- K001375 — ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K993805 — NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.